Drug profile

DOBUTAMINE

Dobutrex

injection

250 mg per 5 ml ampule

Store away from light & moisture at 15-30ᵒC(59-86ᵒF)

Brand Name

Manufacture

Dosage Form

Strength

Storage Condition

Dobutamine injection

injection

Store away from light & moisture at 15-30ᵒC(59-86ᵒF)

250mg×20ml

Brand Name

Manufacture

Dosage Form

Strength

Storage Condition

Dobex

injection

250 mg per 5 ml ampule

Store away from light & moisture at 15-30ᵒC(59-86ᵒF)

Brand Name

Manufacture

Dosage Form

Strength

Storage Condition

Dobutamed

injection

250 mg per 5 ml ampule

Store away from light & moisture at 15-30ᵒC(59-86ᵒF)

Brand Name

Manufacture

Dosage Form

Strength

Storage Condition

Dotrex

injection

250 mg per 5 ml ampule

Store away from light & moisture at 15-30ᵒC(59-86ᵒF)

Brand Name

Manufacture

Dosage Form

Strength

Storage Condition

ISTRY

Chemical class

CATECHOLAMINE DERIVATIVES

white crystalline powder ,

Physical Properties

sparingly soluble in water & Alcohol

soluble in pyridine molecular

Molecular weight is 337.84

pka is 9.5

Molecular Formula: C18H23NO3•HCl

PHARMACOK I N E T I C S

absorption :

orally poor

Administered by continuous IV infusion.

Bioavailability:

100%

%age of Protein Binding:

50%(Catecholamines)

Volume of Distribution

0.202+/-0.084 L/Kg

BBB/ Placental BarrierBBB: No Placental Barrier: Not known

Time for onset of action

1-2 mins

Time for Peak Blood level

10 -12 mins

METABOLISM AND EXCRETION

•Site of MetabolismLiver

•Active metaboliteNo

•Half life2 mins

•Route of excretionMajor: Urine

Minor: Faeces

THERAPEUTIC/ PHARMACOLOGICAL CLASS

•β -1 adrenergic agonist•Inotropic sympathomimetic • Cardiotonic Agents

Mechanism Of Action

It directly effects β -1 receptor & stimulates adenylyl cyclase

produces cAMP

activates kinase protein phosphorylate Ca channel

influx of Ca+2

contractility of heart & stroke volume that cardiac output.

It has mild effect on β-2 & α receptors so reduces vascular resistance.

Indication/ Therapeutic Use

• Inotropic support in Infarction• Septic shock• Cardiogenic shock• Cardiac surgery• Cardiomyopathies• Cardiac decompensation after

cardiac surgery• Pharmacologic Cardiac stress

test

Adverse Effects•Tachycardia

•Marked increase in systolic BP

•Phlebitis•Nausea •Headache

Rare:ThrombocytopeniaShortness of breath

ArrhythmiasAngina pain

Contraindication/ Precaution

• Pregnancy Category B• Idiopathic

hypertrophic sub aortic stenosis• Hypersensitivity to

dobutamine or bisulfites

DOSAGE AND ADMINISTRATION:SR.NO Indication Route of

AdministrationRecommended Dosage Range Duration of

therapy

Infants/Neonates mg/Kg/day & Frequency

Child Adult

1. Cardiac inotropic agent

Continuous iv infusion

2-15 mcg/kg/min 5ug/kg initially then 2-20 ug/kg/min afterwards

2.5-5ug upto 40mcg/kg/min

Shouldnot exceed from 48 hrs

2. Cardiac decompensation

Continuous iv infusion

2-15 mcg/kg/min Shouldnot exceed from 48 hrs

3. Acute heart failure Continuous iv infusion

2-15 mcg/kg/min 2.5-10 ug/kg/min

Shouldnot exceed from 48 hrs

4. Cardiac shock Continuous iv infusion

2-15 mcg/kg/min 5ug/kg/min for 8min then upto 20 ug/kg/min

Shouldnot exceed from 48 hrs

5.

Guidelines FOR IV ROUTE:

Compatible IV fluids Incompatibilities

soluble in alcohol and pyridine intravenous solutions as a diluent: 5% Dextrose Injection, 5% Dextrose and 0.45% Sodium Chloride Injection

incompatible with alkalinesolutions such as sodium bicarbonate 5% and alkaline drugs suchas aminophylline, furosemide,and thiopental sodium

Storage time & temperature after reconstruction

Store in air tight container at 15-30 o , use within 24 hrs

DRUG-DRUG INTERACTION:

Tricyclic antidepressants

Tricyclic antidepressants (TCAs) may markedly enhance the pressor response to parenteral direct-acting sympathomimetic agents The mechanism is TCA inhibition of norepinephrine reuptake in adrenergic neurons, resulting in increased stimulation of adrenergic receptors.

Parenteral administration of direct-acting sympathomimetic agents should preferably be avoided during therapy with tricyclic antidepressants except in cases of emergency (e.g., treatment of anaphylaxis). If concomitant use is necessary, initial dose and rate of administration of the sympathomimetic should be reduced, and cardiovascular status including blood pressure should be monitored closely

Mechanism

Recommendation

Beta blockersBeta-blockers may antagonize the cardiostimulatory effects of pressor agents by blocking beta-1 adrenergic receptors in the heart. In addition, peripheral vascular resistance may increase due to unopposed alpha-adrenergic effects of pressor agents in the presence of beta-blockade

No specific intervention is necessary, but pharmacist should be alert to the potential for diminished cardiac response when pressor agents are used in patients treated with beta-blockers, including ophthalmic formulations.

Mechanism

Recommendation

DRUG-LAB INTERACTION:

 produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.

Toxic Dose

Sign & Symptoms

Rare

anorexia,nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropic and chronotropic effects of dobutamine on the myocardium may causehypertension, tachyarrhythmias

toxicology

• discontinuing administration,• establishing an airway, • ensuring oxygenation and ventilation.

Resuscitative measures should be initiated promptly.

• Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine.

• Hypertension usually responds to a reduction in dose or discontinuation of therapy.

• Protect the patient’s airway and support ventilation and perfusion.

Management/Treatment

We recommend :

Dobutrex

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